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COMPLETED
NCT07532577
PHASE2/PHASE3

Intranasal Insulin to Prevent Intensive Care Unit Delirium

Sponsor: Radboud University Medical Center

View on ClinicalTrials.gov

Summary

This study aims to assess the feasibility, tolerability, and exploratory efficacy of intranasal insulin to prevent delirium in ICU patients aged ≥65 years after complex elective cardiac surgery with cardiopulmonary bypass

Official title: Intranasal Insulin for the Prevention of Delirium in ICU Patients Undergoing Elective Cardiac Surgery: a Randomized, Double-blind, Placebo-controlled Pilot Trial (INSPIRE)

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-04-30

Completion Date

2026-07-30

Last Updated

2026-08-03

Healthy Volunteers

No

Interventions

DRUG

Intranasal insulin-40U

Intranasal isophane insulin administered twice daily. Each administration consists of two sprays of 10 IU (0.1 ml) in alternating nostrils, totalling to 40 IU per day.

DRUG

Intranasal sodium chloride 0.9%

Intranasal sodium chloride 0.9% administered twice daily. Each administration consists of two sprays of 0.1 ml in alternating nostrils, totalling to 0.4mL per day.

Locations (1)

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands